Author: Peter

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The cost to healthcare companies for U.S. regulatory review of their products, including drugs and medical devices, would more than double under the Trump administration's proposed 2018 budget…over $2 billion in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017...it also offered measures that would help speed up the approval process for new drugs and other products...The FDA has been charging companies to review their products since 1992. Most of the user fees collected are for prescription drugs - around $866 million estimated in 2017 - and generic drugs - around $324 million...The budget does not say if the fee increases would be evenly spread or directed in a particular area. The budget did not provide specifics on what measures to speed up approvals might include...

The FDA has suggested an Indian API maker hire a consultant that understands FDA regulations after finding the company didn’t have a grasp of some basic requirements, including how to make sure the water that comes from a nearby river is sanitary before using it to make its products...In a warning letter to Badrivishal Chemicals & Pharmaceuticals, the FDA said its plant in Maharashtra has been using the river water since 2014 without scientific evidence that the system is capable of producing water that meets quality standards...plant employees knew the water for months was out of spec for total aerobic microbial counts when it was used in production, but they didn’t investigate or even seem to understand the process that the plant’s water system relies on to kill microorganisms...water was only one of the problems FDA investigators found...Records were found in trash bags behind a building that showed test results that were different from what had been officially recorded...

Industry groups are taking aim at a rule created by the Food and Drug Administration that could restrict drugmakers' truthful and non-misleading promotion of its drugs — commonly referred to as off-label promotion — by expanding the evidence the agency can use to assert that a drug has been misbranded...For example, under the new rule — pertaining to the FDA's definition of intended use — if a manufacturer discovers that one of its products is being used off-label and, as a result, adjusts its supply and scales its manufacturing to meet higher demand for those off-label uses, the FDA could use the company's internal documents describing that intention to scale up as evidence of a new intended use...The agency expanded the definition of intended use to now include “totality of evidence.”...The new intended use rule exposes manufacturers to a significant risk of liability for conduct that is entirely lawful and beneficial to the public health...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

A multi-agency effort to improve community health in Southern Nevada is making progress…Officials involved in the Community Health Improvement Plan detailed several areas of progress for the initiative…

• A program that will switch 911 emergency callers with low-priority health issues to a hotline manned by an on-call nurse is expected to start in July…
• The district’s mobile health clinics are on course to expand their presence in areas with a dearth of health care facilities and services starting in June.
• An effort to target obesity and tobacco usage by promoting active lifestyles and healthy eating has gained momentum...an app called Neon to Nature, which promotes using walking and biking trails, have exceeded goals, and officials have success in enrolling students in smoking prevention programs and getting schools to participate in fitness programs...

The U.S. Department of Health and Human Services announced...that Nevada will expand mental health care services with the implementation of new community-based behavioral health care clinics...The whole idea is to try to provide better integrative care to individuals that have both substance abuse and mental disorders...We’ve never done well in this state, and probably most other states, in coordinating so that patients are getting care by the same team…the two-year Certified Community Behavioral Health Clinic...will offer 24-hour mobile crisis services, outpatient mental health and substance abuse treatment as well as recovery support.

It may have been too good to last. After an upswing in pharma's global reputation in 2015, its standing among patient groups has swung the other way—again. Only 38% of patient groups said the industry had either an "excellent" or "good" reputation, down from almost 45% last year...after last year’s peak, pharma scores dropped across all the measurements in PatientView's annual survey, including innovation, transparency, pricing, ethical marketing and high-quality, useful products...Almost all of the other healthcare segments...from biotech to insurers, also dropped in their esteem. The only exception was not-for-profit insurers.

• Blame President Donald Trump...with his very public criticisms of pharma "getting away with murder" and his vows to bring down drug prices.
• Then there's the ongoing pricing debate…
• ...another part of the reason for the overall declines may be that, as patient groups become a more important part of the healthcare conversation and infrastructure, they feel more confident speaking their minds...

How would a "competitive bidding process" for drugs work? We may soon find out, if President Donald Trump gets his way with the Republican healthcare bill...Trump assured supporters at a...rally that drug prices are still a top priority for him…he's working quickly to get a drug-bidding measure into the current repeal-and-replace bill...Pushing for more competition in pharma isn’t an unfamiliar refrain from the president, who highlighted his desire for bidding during an infamous pre-inauguration press conference...Trump famously said pharma is "getting away with murder."...Trump...continues to maintain that drug prices are way too high. And he often leaves industry watchers clamoring for details about proposals to bolster competition—competitive bidding included...Trump selected Scott Gottlieb to lead the FDA, who could move to boost competition by enacting changes at the agency to speed new products to market...It remains to be seen what kind of proposals might emerge, but Trump himself favors Medicare price negotiations…

Medicine on the Move...The unusual clinic on wheels is a partnership between Health Plan of Nevada and Southwest Medical Associates. It has been operating since April, as many as six days a week. Drivers Ernie Drown and Chris Philips take the 45-foot truck to locations across the state, but primarily in Southern Nevada...The clinic can handle immunizations, X-rays, ultrasounds, and physical and laboratory exams. It has been to the Las Vegas Rescue Mission, FamilyConnect, St. Patrick’s Church food pantry, the Volunteers of America shelter for the homeless and more...The idea behind the mobile clinic was that we really need to reach our patients out in the community and make it easy for them to access health care,"’ said Toni Corbin, senior vice president of operations at Southwest Medical Associates. "We’re taking health care on the road to where it’s needed."